Introduction to risk management plans in the Singapore context.

Author: Christine Su Ching HO ¹ ; Liesbet Li Bei TAN ¹ ; Cheng Leng CHAN ²
Author Information

1. Product Risk Management Unit, Vigilance and Compliance Branch, Health Products Regulation Group, Health Sciences Authority, Singapore.
2. Health Products Regulation Group, Health Sciences Authority, Singapore.
Publication Type:Journal Article
Keywords: pharmacovigilance; risk management; risk management plans; risks
From:Singapore medical journal 2019;60(9):483-486
CountrySingapore
Language:English
Abstract: A risk management plan (RMP) contains an overview of important safety concerns associated with the use of a therapeutic product (TP) and proposed pharmacovigilance activities to monitor and manage these safety concerns in the post-approval stage. The Health Sciences Authority (HSA) of Singapore has legislated its requirements for RMPs as part of its product life cycle approach in the management of safety concerns associated with TPs. Under the Health Product (Therapeutic Products) Regulations enacted in November 2016, companies may be required to implement RMPs under the direction of HSA to help ensure that the benefits of TPs outweigh their risks. In this commentary, we present a case study on the local RMP for Dengvaxia®, the world's first dengue vaccine, which has been approved for use in Singapore. We hope that this article raises awareness among healthcare professionals about the concept of RMPs and how RMPs are implemented locally.